After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in ...

After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm with the ...

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

The FDA signed off on KalVista Pharmaceuticals' emergency treatment for swelling attacks associated with a rare, genetic ...

Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due ...

KalVista Pharma has finally received FDA approval for its oral kallikrein inhibitor sebetralstat, becoming the first ...

The health secretary has used peer pressure to persuade food makers to nix synthetic dyes. The candy industry is holding out, ...

Despite rehiring hundreds of FDA, CDC and NIH employees, the Department of Health and Human Services is still a skeleton of ...

The cuts have come as FDA Commissioner Dr. Marty Makary has publicly touted plans to expand foreign surprise inspections, despite the agency privately struggling to keep up with inspections due to ...

A nasal spray for treatment-resistant depression has delivered strong clinical results and rekindled investor hopes.

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

Following the dismissal of members from the CDC's vaccine advisory committee, a federal health expert predicts the changes on ...